EP0698397B1 - Radiation compatible lubricant for medical devices - Google Patents

Radiation compatible lubricant for medical devices Download PDF

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Publication number
EP0698397B1
EP0698397B1 EP95305526A EP95305526A EP0698397B1 EP 0698397 B1 EP0698397 B1 EP 0698397B1 EP 95305526 A EP95305526 A EP 95305526A EP 95305526 A EP95305526 A EP 95305526A EP 0698397 B1 EP0698397 B1 EP 0698397B1
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EP
European Patent Office
Prior art keywords
vitamin
silicone
lubricant
irradiated
viscosity
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EP95305526A
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German (de)
French (fr)
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EP0698397A1 (en
Inventor
Mohammad A. Khan
David P. Hopkins
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Becton Dickinson and Co
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Becton Dickinson and Co
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/08—Radiation
    • A61L2/081—Gamma radiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/08—Materials for coatings
    • A61L29/085—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/143—Stabilizers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20—Targets to be treated
    • A61L2202/24—Medical instruments, e.g. endoscopes, catheters, sharps
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/31504—Composite [nonstructural laminate]
    • Y10T428/31652—Of asbestos
    • Y10T428/31663—As siloxane, silicone or silane

Definitions

  • This invention relates in general to a radiation compatible lubricant for a medical device such as an intravenous (IV) catheter and introducer needle assembly.
  • IV intravenous
  • IV catheters are designed to infuse normal intravenous solutions, including antibiotics and other drugs, into a patient. These catheters are also used to withdraw blood from the patient for normal blood-gas analysis as well as other blood work.
  • a sharp introducer needle must be used to puncture the skin, tissue and vein wall to provide a path for placement of the catheter in the vein.
  • Typical IV catheters are "over-the-needle" catheters where the catheter is coaxially placed over the needle. Placement of the catheter and the introducer needle into the patient causes sharp pain to the patient.
  • the catheter and needle can both be lubricated.
  • Most IV catheters are lubricated with polydimethyl siloxane silicone fluid or modified polydimethyl siloxane such as an amino-terminated, carboxy-terminated or polyether silicone copolymer, see US 5,266,359 or EP 491,547.
  • IV catheters communicate with blood and tissues, these devices must be sterilized.
  • the most commonly used method of sterilization is exposing the device to ethylene oxide.
  • the alternative method is exposing the device to gamma rays or electron beams. Ultraviolet or x-rays may also be used.
  • the viscosity of the silicone fluid increases which affects the lubricity of the device. This effect is dependent upon the molecular weight of the specific silicone molecule as well as the exposure dose. For example, the viscosity of less viscous silicone fluid after irradiation may increase several fold and the material may remain as a liquid.
  • a silicone fluid having a viscosity of 1 ⁇ 10 6 mm 2 /s (one million centistokes) may turn into a silicone rubber after it is irradiated. This characteristic will obviously have a deleterious effect on lubricity and the performance of the product.
  • Irradiation of the catheter also effects the polymer from which the catheter is formed. It is well known that irradiation of polymeric materials causes changes in the molecular structure. Usually these changes are destructive resulting in the degradation of molecules. Very often these degraded molecules exist initially in the form of ionic species or free radicals. If these free radicals are quenched as soon as they are formed, the net result is the lowering of the molecular weight of the polymer. If the irradiated material was in the form of a solution in certain solvents, the viscosity of the solution is greatly reduced.
  • a good example is that of polyvinylpyrrolidone. When this polymer is irradiated in water solutions it gels to a thick mass. Whether gelation or degradation will occur after irradiation depends on the nature of the molecule and its environment. Most polymeric materials degrade after irradiation and few of them polymerize and cross-link after exposure to irradiation.
  • the lubricant of this invention comprises a mixture of a silicone lubricant and vitamin E or its derivatives such as vitamin E acetate.
  • vitamin E as an anti-aging compound.
  • the process of aging is related to time-dependent changes occurring in the cells and tissues. These deleterious changes are related to free radical reactions continuously occurring. These free radical reactions normally involve oxygen in mammalian systems. Since vitamin E is an antioxidant, its presence in the cells and tissues either prevents or inhibits these reactions. Thus, the aging process is slowed down. It is now believed that the life span of a healthy individual can be increased by five or more years as a result of vitamin E supplemented diets.
  • vitamin E alpha-tocopherol
  • vitamin E acetate a certain concentration of vitamin E (alpha-tocopherol) or its derivative such as vitamin E acetate will inhibit the effects of irradiation by quenching the free radicals. Addition of vitamin E or its derivative stabilizes the silicone lubricant after irradiation. It is to be noted that the choice of vitamin E is based upon the fact that it is an excellent antioxidant and is a non-toxic metabolizable radiation stabilizer. Since vitamin E is an antioxidant it prevents degradation of the lubrication solution through oxidation and thus minimizes the effects of aging. Naturally occurring vitamin E, also known as alpha-tocopherol, is found in high concentrations of wheat germ, corn and soybean oils. The molecular structure of vitamin E is given below:
  • Vitamin E or its derivative vitamin E acetate, in concentrations of between 0.5% to 20% will work according to this invention, all percentages herein being by weight.
  • vitamin E or its derivative should be used in a concentration of about 2.0% to about 4.0%.
  • Vitamin E can be used on most polymers that are used for medical devices and can be applied to all silicone based lubricants.
  • the first series consisted of mixing vitamin E with silicone, irradiating the material and measuring the viscosity.
  • the second series consisted of preparing the silicone lubricant with vitamin E added, dipping the catheter and introducer needle separately, and then assembling the catheters. The assemblies were irradiated and the tip adhesion was measured.
  • a specified amount of vitamin E was mixed into a commercially available silicone lubricating fluid.
  • the viscosity of the resulting mixture was measured using a Brookfield viscometer.
  • the commercially available silicone fluids employed were (1) Dow Corning 360 polydimethyl siloxane having a viscosity of 350 mm 2 /s (350 centistokes (cstk)), (2) Dow Corning 360 polydimethyl siloxane having a viscosity of 12500 mm 2 /s (12,500 cstk), and (3) Union Carbide polydimethyl siloxane polyether modified Silwet 7001.
  • the silicone vitamin E mixture was gamma irradiated and the viscosity was again measured. Some of the irradiated samples were aged at room temperature for approximately 2 1 ⁇ 2 years. The viscosity of the aged samples was measured as well.
  • Vitamin E (%) Silicone (%) Viscosity (mPas, Centipose) Dow 360 (12,500 mm 2 /s (cstk)) 0 Gy (0 Mrad) 3x10 4 Gy (3 Mrad) 3x10 4 Gy (3 Mrad) aged 2 1/2 years 0.00 100.00 12900 49840 62000 0.50 99.50 12910 25880 26400 1.00 99.00 12930 23800 24000 1.50 98.50 12870 22900 24000 2.00 98.00 12600 22440 23200 2.50 97.50 12560 21600 22200 3.00 97.00 12560 21200 23200
  • Vitamin E (%) Silicone (%) Viscosity (mPas, Centipose) Union Carbide Silwet 7001 0 Gy (0 Mrad) 2.6x10 4 Gy (2.6 Mrad) 5.3x10 4 Gy (5.3 Mrad) 5.3x10 4 Gy (5.3 Mrad) aged 2 1/2 years 0 100 2300 2760 2950 2850 2 98 2050 2236 2300 2260 4 96 2100 2116 2150 2110 8 92 1950 1978 2000 2000 16 84 1850 1840 1800 1850 32 68 1360 1362 1350 1300
  • silicone lubricant and vitamin E were dissolved in Freon TF.
  • the needles and catheters which were 20 gauge (ga), were dipped separately.
  • the needles used dimethylsiloxane 1.10 6 mm 2 /s (1MM cstk).
  • the needles were heated at 70°C for half an hour and then allowed to cool to room temperature.
  • the catheters used Dow Corning 360 polydimethyl siloxane having a viscosity of 12500 mm 2 /s (12,500 cstk).
  • the needle and catheter assemblies were then assembled.
  • the products were divided into two groups. The first group was retained as a control and the second group was exposed to gamma irradiation at a specified dose. a These products were also aged at 60°C and 90°C respectively.
  • Vitamin E (%) Vitamin E (g) Lubricant (g) Solvent (g) Vitamin E (g) Lubricant (g) Solvent (g) 0 0 3.98 196.02 0 4.79 195.21 2 0.081 3.88 196.04 0.098 4.82 195.08 4 0.181 3.84 196.00 0.192 4.63 195.17 8 0.325 3.64 196.04 0.376 4.46 195.16 16 0.655 3.39 196.00 0.762 4.00 195.24
  • the control lubricant contained 2.4% 1 ⁇ 10 6 mm 2 /s (1MM cstk) silicone.
  • the experimental lubricant contained 0.048% vitamin E and 2.35% 1 ⁇ 10 6 mm 2 /s (1MM cstk) silicone.
  • the silicone in both lubricants was dissolved in Freon TF.
  • a control catheter lubricant contained 2.0% Dow Corning 360 (12500 mm 2 /s, 12,500 cstk) silicone. Again, the silicone in both lubricants was dissolved in Freon TF.
  • Vitamin E does provide inhibitory effect against the free radicals generated due to radiation and prevents the viscosity increase.
  • Silwet L7001 silicone surfactant which is from a class of such compounds known as polyalkyleneoxide dimethylsiloxane copolymer manufactured by Union Carbide, was used.
  • the compounds are water soluble and can be used as lubricants.
  • a series of water solutions containing different amounts of Silwet L7001 and Vitamin E in water were prepared. These solutions were used to dip the needle as well as the catheter for assembling 20 ga catheter products. These products were divided into two groups. The first group were non-irradiated and the second group were irradiated at 3.3x10 4 Gy, (3.3 Mrad). The catheter tip adhesion in grams was measured.
  • vitamin E shows that it can quench the free radicals generated due to irradiation. It also shows that because of the quenching the increase in tip adhesion is inhibited. The data also shows that the stabilization of the lubricant by vitamin E is concentration dependent.
  • a lubricant is provide that will not deteriorate upon irradiation.

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  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Materials For Medical Uses (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Compositions Of Macromolecular Compounds (AREA)

Description

Background of the Invention
This invention relates in general to a radiation compatible lubricant for a medical device such as an intravenous (IV) catheter and introducer needle assembly.
IV catheters are designed to infuse normal intravenous solutions, including antibiotics and other drugs, into a patient. These catheters are also used to withdraw blood from the patient for normal blood-gas analysis as well as other blood work.
A sharp introducer needle must be used to puncture the skin, tissue and vein wall to provide a path for placement of the catheter in the vein. Typical IV catheters are "over-the-needle" catheters where the catheter is coaxially placed over the needle. Placement of the catheter and the introducer needle into the patient causes sharp pain to the patient. In order to facilitate insertion of the catheter and introducer needle into the vein and to minimize patient discomfort, the catheter and needle can both be lubricated. Most IV catheters are lubricated with polydimethyl siloxane silicone fluid or modified polydimethyl siloxane such as an amino-terminated, carboxy-terminated or polyether silicone copolymer, see US 5,266,359 or EP 491,547.
Since IV catheters communicate with blood and tissues, these devices must be sterilized. The most commonly used method of sterilization is exposing the device to ethylene oxide. The alternative method is exposing the device to gamma rays or electron beams. Ultraviolet or x-rays may also be used. When these lubricated IV catheters are irradiated, the viscosity of the silicone fluid increases which affects the lubricity of the device. This effect is dependent upon the molecular weight of the specific silicone molecule as well as the exposure dose. For example, the viscosity of less viscous silicone fluid after irradiation may increase several fold and the material may remain as a liquid. On the other hand, a silicone fluid having a viscosity of 1·106 mm2/s (one million centistokes) may turn into a silicone rubber after it is irradiated. This characteristic will obviously have a deleterious effect on lubricity and the performance of the product.
Irradiation of the catheter also effects the polymer from which the catheter is formed. It is well known that irradiation of polymeric materials causes changes in the molecular structure. Usually these changes are destructive resulting in the degradation of molecules. Very often these degraded molecules exist initially in the form of ionic species or free radicals. If these free radicals are quenched as soon as they are formed, the net result is the lowering of the molecular weight of the polymer. If the irradiated material was in the form of a solution in certain solvents, the viscosity of the solution is greatly reduced. For example, a.gel made of hydroxyethyl cellulose dissolved in water when irradiated at 2.0 to 5.0 × 104 Gy, (2.0 to 5.0 megarads), becomes a liquid as a result of losing the viscosity. If, on the other hand, the generated free radicals are not quenched, further degradation of the material, repolymerization of the polymer and even cross linking takes place. This can cause either a decrease or an increase in viscosity sometimes to the extent that gelation occurs. A good example is that of polyvinylpyrrolidone. When this polymer is irradiated in water solutions it gels to a thick mass. Whether gelation or degradation will occur after irradiation depends on the nature of the molecule and its environment. Most polymeric materials degrade after irradiation and few of them polymerize and cross-link after exposure to irradiation.
Summary of the Invention
It is therefore an object of this invention to provide a lubricant for a medical device, such as an IV catheter and an introducer needle, that will not degrade when the medical device is sterilized by irradiation.
The lubricant of this invention comprises a mixture of a silicone lubricant and vitamin E or its derivatives such as vitamin E acetate.
The above and other objects of this invention will be apparent upon consideration of the following detailed description.
Detailed Description of the Invention
There is ample information in the scientific literature about vitamin E as an anti-aging compound. The process of aging is related to time-dependent changes occurring in the cells and tissues. These deleterious changes are related to free radical reactions continuously occurring. These free radical reactions normally involve oxygen in mammalian systems. Since vitamin E is an antioxidant, its presence in the cells and tissues either prevents or inhibits these reactions. Thus, the aging process is slowed down. It is now believed that the life span of a healthy individual can be increased by five or more years as a result of vitamin E supplemented diets.
Incorporation of a certain concentration of vitamin E (alpha-tocopherol) or its derivative such as vitamin E acetate will inhibit the effects of irradiation by quenching the free radicals. Addition of vitamin E or its derivative stabilizes the silicone lubricant after irradiation. It is to be noted that the choice of vitamin E is based upon the fact that it is an excellent antioxidant and is a non-toxic metabolizable radiation stabilizer. Since vitamin E is an antioxidant it prevents degradation of the lubrication solution through oxidation and thus minimizes the effects of aging. Naturally occurring vitamin E, also known as alpha-tocopherol, is found in high concentrations of wheat germ, corn and soybean oils. The molecular structure of vitamin E is given below:
Figure 00040001
Vitamin E, or its derivative vitamin E acetate, in concentrations of between 0.5% to 20% will work according to this invention, all percentages herein being by weight. Preferably, vitamin E or its derivative should be used in a concentration of about 2.0% to about 4.0%. Vitamin E can be used on most polymers that are used for medical devices and can be applied to all silicone based lubricants.
To demonstrate the effectiveness of vitamin E to inhibit the effects of irradiation, two series of experiments were conducted. The first series consisted of mixing vitamin E with silicone, irradiating the material and measuring the viscosity. The second series consisted of preparing the silicone lubricant with vitamin E added, dipping the catheter and introducer needle separately, and then assembling the catheters. The assemblies were irradiated and the tip adhesion was measured.
In the first series of experiments, a specified amount of vitamin E was mixed into a commercially available silicone lubricating fluid. The viscosity of the resulting mixture was measured using a Brookfield viscometer. The commercially available silicone fluids employed were (1) Dow Corning 360 polydimethyl siloxane having a viscosity of 350 mm2/s (350 centistokes (cstk)), (2) Dow Corning 360 polydimethyl siloxane having a viscosity of 12500 mm2/s (12,500 cstk), and (3) Union Carbide polydimethyl siloxane polyether modified Silwet 7001. The silicone vitamin E mixture was gamma irradiated and the viscosity was again measured. Some of the irradiated samples were aged at room temperature for approximately 2 ½ years. The viscosity of the aged samples was measured as well.
Example No. 1
Vitamin E(%) Silicone (%) Viscosity (m Pas, Centipoise)
Dow 360 (350 mm2/s (cstk)) 0 Gy (0 Mrad) 3 x 104 Gy (3 Mrad)
0 100 322 394
0.01 99.99 325 388
0.05 99.95 325 385
0.10 99.90 327 375
0.50 99.50 326 355
1.00 99.00 326 353
Example No. 2
Vitamin E (%) Silicone (%) Viscosity (mPas, Centipose)
Dow 360 (12,500 mm2/s (cstk)) 0 Gy (0 Mrad) 3x104 Gy (3 Mrad) 3x104 Gy (3 Mrad) aged 2 1/2 years
0.00 100.00 12900 49840 62000
0.50 99.50 12910 25880 26400
1.00 99.00 12930 23800 24000
1.50 98.50 12870 22900 24000
2.00 98.00 12600 22440 23200
2.50 97.50 12560 21600 22200
3.00 97.00 12560 21200 23200
Example No. 3
Vitamin E (%) Silicone (%) Viscosity (mPas, Centipose)
Union Carbide Silwet 7001 0 Gy (0 Mrad) 2.6x104 Gy (2.6 Mrad) 5.3x104 Gy (5.3 Mrad) 5.3x104 Gy (5.3 Mrad) aged 2 1/2 years
0 100 2300 2760 2950 2850
2 98 2050 2236 2300 2260
4 96 2100 2116 2150 2110
8 92 1950 1978 2000 2000
16 84 1850 1840 1800 1850
32 68 1360 1362 1350 1300
The above examples clearly demonstrate that vitamin E, if present in silicone, inhibits the increase in viscosity after the mixture is irradiated.
In the second series of experiments, silicone lubricant and vitamin E were dissolved in Freon TF. The needles and catheters, which were 20 gauge (ga), were dipped separately. The needles used dimethylsiloxane 1.106 mm2/s (1MM cstk). The needles were heated at 70°C for half an hour and then allowed to cool to room temperature. The catheters used Dow Corning 360 polydimethyl siloxane having a viscosity of 12500 mm2/s (12,500 cstk). The needle and catheter assemblies were then assembled. The products were divided into two groups. The first group was retained as a control and the second group was exposed to gamma irradiation at a specified dose. a These products were also aged at 60°C and 90°C respectively.
Example No. 4
Catheter Lubricant Needle Lubricant
Vitamin E (%) Vitamin E (g) Lubricant (g) Solvent (g) Vitamin E (g) Lubricant (g) Solvent (g)
0 0 3.98 196.02 0 4.79 195.21
2 0.081 3.88 196.04 0.098 4.82 195.08
4 0.181 3.84 196.00 0.192 4.63 195.17
8 0.325 3.64 196.04 0.376 4.46 195.16
16 0.655 3.39 196.00 0.762 4.00 195.24
These products were tested for tip adhesion. The results are given in grams.
Tip Adhesion (grams)
Vitamin E % Non-irradiated Irradiated at (2.7 Mrad) 2.7x104 Gy
0 241.5 (20.9) 303.7 (43.6)
2 212.0 (32.7) 289.2 (15.4)
4 222.0 (12.7) 282.4 (35.4)
8 214.7 (23.2) 265.1 (15.4)
16 234.7 (20.9) 267.4 (15.9)
Note: ( ) = standard deviation
The above data clearly demonstrated the ability of Vitamin E to inhibit the increase in tip adhesion of the product.
The above products were aged at 90°C for two weeks. The tip adhesion of these aged products were measured. The results are tabulated below:
Tip Adhesion (grams)
Vitamin E % Non-irradiated Irradiated at (2.7 Mrad) 2x104 Gy
0 522.6 (67.2) 577.9 (94.0)
2 383.2 (37.7) 495.3 (64.9)
4 377.3 (83.1) 528.9 (76.3)
8 410.4 (88.1) 521.6 (81.7)
16 460.3 (80.3) 565.2 (90.0)
Note: ( ) = standard deviation
From the above data it appears that for this system 2% - 4% of vitamin E in silicone fluid will provide the optimum protection. The above also shows the effect of aging and the concentration of vitamin E on tip adhesion of the product.
Example No. 5
In this experiment, two sets of needle lubricants were prepared. The control lubricant contained 2.4% 1·106mm2/s (1MM cstk) silicone. The experimental lubricant contained 0.048% vitamin E and 2.35% 1·106 mm2/s (1MM cstk) silicone. The silicone in both lubricants was dissolved in Freon TF. Similarly, a control catheter lubricant contained 2.0% Dow Corning 360 (12500 mm2/s, 12,500 cstk) silicone. Again, the silicone in both lubricants was dissolved in Freon TF. These products were divided into three groups as follows:
Group A:
non-irradiated, control and aged at 60°C and 90°C
Group B:
irradiated at (3.0 Mrad) 3x104 Gy and aged at 60°C
Group C:
irradiated at (3.0 Mrad) 3x104 Gy and aged at 90°C
The results of tip adhesion in grams at various intervals are tabulated below:
Days in Aging, 60°C Group A Group B
0 260.6 (12.3) 199.3 (12.3)
10 358.2 (57.2) 269.7 (44.5)
24 364.6 (36.8) 309.2 (91.7)
41 408.1 (45.4) 326.4 (69.9)
64 431.3 (27.2) 343.7 (64.0)
Note: ( ) = standard deviation
Days in Aging, 90°C Group A Group C
0 260.6 (12.3) 199.3 (12.3)
7 412.7 (59.5) 316.4 (33.1)
21 470.3 (67.6) 376.4 ( 7.2)
38 567.0 (103.5) 463.5 (81.7)
61 449.3 (115.3) 587.0 ( 0.8)
Note: ( ) = standard deviation
Again, it is very clear from the data that Vitamin E does provide inhibitory effect against the free radicals generated due to radiation and prevents the viscosity increase.
Example No.6
In this example, Silwet L7001 silicone surfactant, which is from a class of such compounds known as polyalkyleneoxide dimethylsiloxane copolymer manufactured by Union Carbide, was used. The compounds are water soluble and can be used as lubricants. A series of water solutions containing different amounts of Silwet L7001 and Vitamin E in water were prepared. These solutions were used to dip the needle as well as the catheter for assembling 20 ga catheter products. These products were divided into two groups. The first group were non-irradiated and the second group were irradiated at 3.3x104 Gy, (3.3 Mrad). The catheter tip adhesion in grams was measured. The results are tabulated below:
Composition Tip Adhesion (g) before aging
Vitamin E (g) Silwet L7001 (g) Water (g) non-irradiated Irradiated at (3.3 Mrad) 3.3x104Gy
0 2 98 227.9 (30.4) 236.5 (27.2)
0 4 96 218.4 (37.7) 119.9 (17.7)
0.08 1.92 98 225.6 (11.4) 227.9 (15.4)
0.16 3.84 96 234.3 (13.2) 228.4 (13.2)
0.24 5.76 94 229.3 (22.7) 237.4 (12.3)
Note: ( ) = standard deviation
The above products were aged at 90°C for four days. The tip adhesion in grams was again measured. The results are tabulated below:
Composition Tip Adhesion (g) before aging
Vitamin E (g) Silwet L7001 (g) Water (g) non-irradiated Irradiated at (3.3 Mrad) 3.3x104 Gy
0 2 98 196.6 (66.7) 414.0 (127.6)
0 4 96 216.6 (112.6) 361.4 (93.1)
0.08 1.92 98 238.8 (36.32) 239.3 (69.9)
0.16 3.84 96 196.6 (50.3) 247.4 (50.8)
0.24 5.76 94 120.8 (83.5) 199.8 (74.0)
Note: ( ) = standard deviation
water = deionized sterile
In this example, again, vitamin E shows that it can quench the free radicals generated due to irradiation. It also shows that because of the quenching the increase in tip adhesion is inhibited. The data also shows that the stabilization of the lubricant by vitamin E is concentration dependent.
Thus, it is seen that a lubricant is provide that will not deteriorate upon irradiation.

Claims (5)

  1. A medical device coated with vitamin E or vitamin E acetate and a silicone based lubricant.
  2. The medical device of Claim 1 wherein the vitamin E or vitamin E acetate comprises between about 2.0 wt% to about 4.0 wt% of the lubricant.
  3. The medical device of either Claim 1 or 2 wherein the silicone based lubricant is selected from the group consisting of polydimethylsiloxane and a block copolymer polyalkylene oxide modified polydimethylsiloxane.
  4. A method of sterilizing a medical device, comprising:
    coating the medical device with a mixture of vitamin E or vitamin E acetate and a silicone lubricant; and
    irradiating the medical device.
  5. The method of Claim 4 wherein the vitamin E or vitamin E acetate comprises between about' 2.0 wt% to about 4.0 wt% of the lubricant.
EP95305526A 1994-08-22 1995-08-08 Radiation compatible lubricant for medical devices Expired - Lifetime EP0698397B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US29421394A 1994-08-22 1994-08-22
US294213 1994-08-22

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EP0698397B1 true EP0698397B1 (en) 2002-02-13

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EP (1) EP0698397B1 (en)
JP (1) JP2731757B2 (en)
CA (1) CA2154118A1 (en)
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ES (1) ES2172558T3 (en)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5589120A (en) * 1994-08-22 1996-12-31 Becton Dickinson And Company Process of making a shaped tip on a catheter
US6986868B2 (en) 1998-11-20 2006-01-17 Coloplast A/S Method for sterilizing a medical device having a hydrophilic coating
EP1961429A3 (en) 1998-11-20 2008-09-24 Coloplast A/S A method for sterilising a medical device having a hydrophilic coating
US7332227B2 (en) * 2003-03-14 2008-02-19 Becton, Dickinson And Company Non-volatile lubricant system for medical devices
US8870814B2 (en) * 2003-07-31 2014-10-28 Boston Scientific Scimed, Inc. Implantable or insertable medical devices containing silicone copolymer for controlled delivery of therapeutic agent
EP2035045A1 (en) * 2006-06-01 2009-03-18 DSMIP Assets B.V. Sterilisation of a medical device by irradiation
US20110301553A1 (en) * 2010-06-04 2011-12-08 Smiths Medical Asd, Inc. Antimicrobial lubricant
EP2617774B1 (en) 2010-09-17 2015-03-04 Terumo Kabushiki Kaisha Silicone rubber composition
WO2014098864A1 (en) 2012-12-20 2014-06-26 Becton, Dickinson And Company Device and method for inhibiting movement of a medical device in a patient
DK3248620T5 (en) * 2016-05-25 2022-08-29 Teleflex Life Sciences Pte Ltd Method for manufacturing a ready-to-use catheter unit and ready-to-use catheter unit

Family Cites Families (30)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA975500A (en) * 1969-02-06 1975-09-30 Joseph G. Spitzer Structures such as applicator pads for cleaning and other purposes, propellant compositions for forming the same, and process
US3949067A (en) * 1974-06-14 1976-04-06 Gibbs Harold E Shaving lubricant
US4459318A (en) * 1981-11-09 1984-07-10 American Hospital Supply Corporation Method for forming a self-lubricating fill tube
DE3378461D1 (en) * 1982-09-09 1988-12-22 Terumo Corp Artificial organ and method for manufacturing thereof
JPS59197256A (en) * 1983-04-25 1984-11-08 テルモ株式会社 Medical bag and production thereof
US4686124A (en) * 1983-12-12 1987-08-11 Sumitomo Bakelite Company Ltd. Thermoplastic resin-silicone rubber composite shaped article
DE3582523D1 (en) * 1984-07-16 1991-05-23 Sumitomo Bakelite Co CONTAINER AND METHOD FOR STORING BLOOD.
US4994265A (en) * 1985-09-06 1991-02-19 Aloe Scientific Labs Shaving composition
US4720521A (en) * 1985-12-03 1988-01-19 Becton, Dickinson And Company Film-forming silicone compositions having lubricating properties
US4838876A (en) * 1986-04-29 1989-06-13 The Kendall Company Silicone rubber catheter having improved surface morphology
US4842889A (en) * 1987-08-03 1989-06-27 Becton, Dickinson And Company Method for preparing lubricated surfaces
US4844986A (en) * 1988-02-16 1989-07-04 Becton, Dickinson And Company Method for preparing lubricated surfaces and product
US5061738A (en) * 1988-04-18 1991-10-29 Becton, Dickinson And Company Blood compatible, lubricious article and composition and method therefor
US5013717A (en) * 1988-04-18 1991-05-07 Becton, Dickinson And Company Blood compatible, lubricious article and composition and method therefor
US4904433A (en) * 1989-02-27 1990-02-27 Becton, Dickinson And Company Method for die release during catheter tipping
US5026607A (en) * 1989-06-23 1991-06-25 C. R. Bard, Inc. Medical apparatus having protective, lubricious coating
US5272012A (en) * 1989-06-23 1993-12-21 C. R. Bard, Inc. Medical apparatus having protective, lubricious coating
US5047159A (en) * 1989-08-24 1991-09-10 Henkel Corporation Lubricant compositions having improved anti-deposition properties comprising a polyalkylene oxide-modified silicone oil
US5071706A (en) * 1989-08-31 1991-12-10 Eurand America, Incorporated Oily, free-flowing, microcapsules
US5043161A (en) * 1989-08-31 1991-08-27 Eurand America, Inc. Small, oily, free-flowing, silky-smooth, talc-like, dry microcapsules and aqueous formulations containing them
US5037419A (en) * 1989-09-21 1991-08-06 Eastman Kodak Company Blood bag system containing vitamin E
US4973643A (en) * 1989-12-11 1990-11-27 Siltech Inc. Ether amine fuctional silicone polymers
US5336209A (en) * 1990-04-06 1994-08-09 Porzilli Louis B Multi-function wound protection bandage and medicant delivery system with simultaneous variable oxygenation
US5185006A (en) * 1990-12-17 1993-02-09 Becton, Dickinson And Company Lubricated metal articles and assembly containing same
US5266359A (en) * 1991-01-14 1993-11-30 Becton, Dickinson And Company Lubricative coating composition, article and assembly containing same and method thereof
US5344411A (en) * 1991-02-27 1994-09-06 Leonard Bloom Method and device for inhibiting HIV, hepatitis B and other viruses and germs when using a catheter in a medical environment
AU4401593A (en) * 1992-06-05 1994-01-04 Thomas Medical Products, Inc. Catheter introducer with lubrication means
US5383903A (en) * 1992-08-20 1995-01-24 United States Surgical Corporation Dimethylsiloxane-alkylene oxide copolymer coatings for filaments
US5240675A (en) * 1992-09-24 1993-08-31 Wilk Peter J Method for cleaning endoscope
US5338312A (en) * 1992-10-02 1994-08-16 Becton, Dickinson And Company Article having multi-layered lubricant and method therefor

Also Published As

Publication number Publication date
CA2154118A1 (en) 1996-02-23
JP2731757B2 (en) 1998-03-25
ES2172558T3 (en) 2002-10-01
JPH0866461A (en) 1996-03-12
EP0698397A1 (en) 1996-02-28
US6102898A (en) 2000-08-15
DE69525399T2 (en) 2002-10-17
DE69525399D1 (en) 2002-03-21

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